US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Estradiol cypionate/Test cyprionate

Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

Abbott's Compounding Pharmacy, Inc. D-0678-2016
Class II · Moderate risk Terminated

calcium elemental

Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

Abbott's Compounding Pharmacy, Inc. D-0677-2016
Class II · Moderate risk Terminated

Bupivacaine

Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

Abbott's Compounding Pharmacy, Inc. D-0676-2016
Class II · Moderate risk Terminated

Lyrica

Reason FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

Pfizer Inc. NDC 0071-1014-68 D-0649-2016
Class II · Moderate risk Terminated

Lyrica

Reason FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

Pfizer Inc. NDC 0071-1013-68 D-0648-2016
Class II · Moderate risk Terminated

Guaifenesin DM Cherry liquid

Reason Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Perrigo Company PLC NDC 49348-828-34 D-0587-2016
Class II · Moderate risk Terminated

Guaifenesin Grape liquid 100 mg/5 mL

Reason Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Perrigo Company PLC NDC 37808-288-26 D-0586-2016
Class II · Moderate risk Terminated

Bromfenac Ophthalmic Solution 0.09%

Reason Lack of Assurance of Sterility: Failed preservative effectiveness test

Mayne Pharma Usa NDC 0378-7110-35 D-0585-2016
Class II · Moderate risk Terminated

Baclofen

Reason Lack of assurance of sterility

TexasStar Pharmacy D-0733-2016
Class II · Moderate risk Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg

Reason Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

Macleods Pharma Usa Inc D-0653-2016
Class II · Moderate risk Terminated

IT Custom Compound

Reason Lack of Assurance of Sterility

Amerita Specialty Infusion Services D-0570-2016
Class II · Moderate risk Terminated

Energique

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0135-1 D-0580-2016
Class II · Moderate risk Terminated

Energique

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0134-1 D-0579-2016
Class II · Moderate risk Terminated

Energique

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0137-1 D-0578-2016
Class II · Moderate risk Terminated

Energique

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0133-1 D-0577-2016
Class II · Moderate risk Terminated

Energique

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0132-1 D-0576-2016
Class II · Moderate risk Terminated

Energique

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0136-1 D-0575-2016
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1440-2016
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1439-2016
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1438-2016
Class II · Moderate risk Terminated

Capecitabine tablets USP 500 mg

Reason Failed Dissolution Specifications: low test results at the 18 month time-point

Teva North America NDC 0093-7474-89 D-0732-2016
Class II · Moderate risk Terminated

Ventolin HFA

Reason Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

GlaxoSmithKline, LLC NDC 0173-0682-20 D-0519-2016
Class II · Moderate risk Terminated

Oxygen

Reason cGMP Deviations; trailer may not have met GMP requirements prior to filling

AGA Gas Inc NDC 33237-001-01 D-0779-2016
Class II · Moderate risk Terminated

Dextroamphetamine Saccharate

Reason Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

Teva Pharmaceuticals USA NDC 0555-0972-02 D-0566-2016